Quality agreement for distributors

[MarRz]

Hello,

Our company has quality agreements in place with distributors of our medical device with basic requirements for quality, notification and reporting. Examples of some of the requirements:

• ensure that the Product is stored and shipped in accordance with recommended storage conditions,
• maintain and supply upon request documentation that supports the recommended storage and transportation conditions plus re-evaluation or expiry dates,
• all non-conformance should be investigated. Where applicable, this includes the identification of the root cause, a risk analysis of the actions taken for the correction of the problem, prevention of future occurrence, and the formal conclusion by the Partner’s Quality Assurance. If an investigation reveals that there is an impact on the Product received by the end user, the Partner shall inform the Company without unreasonable delay,

The distributor should be registered as such in his own country. We have never checked or required this from them since this is his own obligation to perform when distributing medical devices. However, with IVDR's liability of all economic operators in the chain, the question arose if we should put this requirement in Quality agreement.
I still don't think that the distributor's failure to register locally as a medical device distributor should be our fault.

What are your thoughts on this? Do you think we should include this requirement in the Quality agreement or leave it as it is since it is the distributor's responsibility to follow local requirements?

 

[yodon]

For me, this goes back to basic qualification and approval of the service provider. Why would you approve a distributor that cannot legally distribute to your intended market?

The "fault" consideration aside, you're still going to be hurt if there is regulatory fall-out. I don't recommend living fast and loose when it comes to regulatory aspects so I try to button things up as tightly as possible.

 

[EmiliaBedelia]

You should clearly specify that the distributor is responsible for registration and following local requirements. Even if the distributor is "legally" required to follow certain requirements per IVDR, you as the manufacturer are responsible for your suppliers. It's not your "fault" if your distributor fails to register, but it is your fault if you knowingly select a distributor that is breaking the law.

Personally, my company previously took the approach of not specifying the requirements in the QA for distributors, with the thought process that the regulation applies to the distributors as well so we don't need to enforce the law. Our NB disagreed with this. Their viewpoint was that the manufacturer is ultimately responsible for ensuring that the product is compliant, so the quality agreements should specify all of the requirements that we expect. IMO it is so easy to simply copy and paste the requirements for the distributor from the regulation, it doesn't make sense to not put it in.

 

[SeanN]

Agreed with Yodon and Emilia. My two cents: You may want to look at other agreements that may be available (but out of QA scope/sight). In your case, there is likely a Distribution Agreement containing your expected piece of info. In my business experience, contents like "the distributor's responsibility to follow local requirements" are usually in Distribution Agreements (containing commercial, legal ...and also QA stuff).

 

[Philip B]

Are we talking here about individual member state requirements for distributors to register? There's no regulatory requirement for this as far as I can see. If so, does anyone have a list of the member states this applies to?

 

[Ed Panek]

Any competent distributor should be aware of all these requirements; this is their core business. Are you utilizing a very small or new company? For a sanity check if you have an NDA in place they can share other clients they may have in similar product areas.

Any distributor that knows what they are doing will direct you to what to do and not the other way around. Their customer reps will do this at least weekly for other customers. Set up a call with them and probe their competence in this area.